Effectiveness and safety of damoctocog alfa pegol in German patients with severe and nonsevere haemophilia A: Sixth interim analysis of the HEM-POWR study

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Introduction At study startdamoctocog alfa pegol, an extended half-life PEGylated recombinant factor VIII (FVIII) product, was approved for treatment of haemophilia A in previously treated patients (PTPs) aged≥12 years; it has more recently been approved in those>7 years. The ongoing, Phase IV HEM-POWR study (NCT03932201) assesses real-world effectiveness and safety of damoctocog alfa pegol. Here, we present results from the sixth interim analysis of HEM-POWR in a subgroup of PTPs from German study sites. Method HEM-POWR includes PTPs with severe and nonsevere haemophilia A receiving damoctocog alfa pegol prophylactically or on demand. The primary endpoint was annualised bleeding rate (ABR); secondary endpoints included safety. PTPs who had a first documented dose of damoctocog alfa pegol, bleeding data and≥1 documented infusion in the patient diary were included in the full analysis set (FAS); the modified FAS (mFAS) included those with≥90 days of observation data documented in the patient diary. The safety analysis set (SAF) included PTPs with signed consent and≥1 study dose during the observation period. Exploratory and descriptive analyses were performed on data from patient diaries and physician records. Results At data cutoff (5 June 2025), 57, 53 and 73 PTPs were included in the FAS, mFAS and SAF, respectively, from German study sites ([ Fig. 2 ]). The median observation period in the FAS was 1171.0 days. The median age was 38.0 years, 80.7% had severe disease and most (94.7%) were treated prophylactically with previous FVIII product prior to the observation period. The most common dosing regimen with previous FVIII product was every 2 days (39/57; 68.4%). During the observation period, the most common regimen was twice weekly at baseline (18/57; 31.6%), 6- (22/57, 38.6%) and 12-month follow-up (22/56, 39.3%). In PTPs with≥2 years of diary documentation in the mFAS (N=32), the mean (standard deviation/median (quartile [Q]1, Q3) ABR for total bleeds with previous FVIII treatment was 2.5 (3.7)/1.0 (0.0, 3.5) and during the observation period with damoctocog alfa pegol was 1.4 (2.7)/0.3 (0.0, 1.4) ([ Fig. 1 ]). The difference in ABR for total bleeds was –1.0 (3.3)/0.0 (–1.6, 0.3), for spontaneous bleeds was –0.8 (2.6)/0.0 (–0.7, 0.0), joint bleeds –1.0 (3.0)/0.0 (–1.0, 0.3), and spontaneous joint bleeds –0.7 (2.1)/ 0.0 (–0.2, 0.0). In the SAF, 39 (53.4%) patients had treatment-emergent adverse events (TEAEs); 14 (19.2%) were serious. TEAEs led to a change of treatment regimen in 15 (20.6%) patients. There were 2 (2.7%) study drug-related TEAEs and 1 special interest, 1 transient inhibitor that resolved and 1 treatment discontinuation. Fig. 2 Mean (SD) ABR in PTPs with≥2 years of diary documentation (mFAS, N=32). Mean (SD) ABR with previous FVIII product in the 12 months prior to damoctocog alfa pegol initiation and with damoctocog alfa pegol during the observation period in PTPs with≥2 years of diary documentation. Total, spontaneous, joint and spontaneous joint bleeds in a German subgroup analysis are presented. Fig. 1 Baseline demographics and clinical characteristics of patients in the SAF and FAS. Patient demographics and characteristics during baseline and observation period in a subgroup analysis of patients from German clinical study sites. Baseline data include sex, age, BMI and disease severity. Conclusion Consistent with previous interim analyses of HEM-POWR, damoctocog alfa pegol demonstrated effectiveness and a favourable safety profile in real-world treatment of PTPs with haemophilia A from German study sites. These updated analyses provide valuable insights to inform real-world clinical practice. Acknowledgments: Editorial support was provided by Natalie Mitchell of Avalere Health Global Limited, and was funded by Bayer. This study was funded by Bayer. Publication History Article published online: 17 February 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

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